[Show abstract][Hide abstract] ABSTRACT: The Standardisation Committee of the European Cystic Fibrosis Society Clinical Trial Network (ECFS-CTN) has undertaken the evaluation of clinical endpoints for therapeutic interventions regarding their use in multicentre clinical trials in CF. This review of biomarkers in bronchoalveolar lavage (BAL) is part of the group's work. The aims of this project were 1) to review the literature on reliability, validity and responsiveness of BAL in patients with CF, 2) to gain consensus of the group on the feasibility of BAL and 3) to gain consensus on answers to key questions regarding the promotion of BAL to surrogate endpoint status. Assessment of BAL inflammatory markers from the literature indicate that their reliability, validity and responsiveness are adequate for clincal trials. The practical characteristics were discussed and it was concluded that BAL has an attractive validity profile albeit with limited feasibility. It is particularly applicable to multicentre trials in preschool children with CF and early or mild lung disease. This is the first article to collate the literature in this manner. This provides rationale to support the use of BAL in early clinical trials in preschool children with CF.
European Respiratory Journal 07/2013; 43(2). DOI:10.1183/09031936.00017713 · 7.64 Impact Factor
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